Indications and uses
temporarily relieves nasal congestion due to common cold hay fever upper respiratory allergies
temporarily relieves nasal congestion due to common cold hay fever upper respiratory allergies
take every 4-6 hours do not take more than 4 doses in 24 hours use only with enclosed dose cup. Do not use with any other device. adults & children 12 years and over 2 TSP children 6 to under 12 years 1 TSP children under 6 years do not use
store at room temperature 15°-30°C (59°-86°F) protect from light
Drug Facts
Pseudoephedrine HCl 30 mg
Nasal decongestant
temporarily relieves nasal congestion due to
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's Disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product.
Ask a doctor before use if you have
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| adults & children 12 years and over | 2 TSP |
| children 6 to under 12 years | 1 TSP |
| children under 6 years | do not use |
artificial raspberry flavor, citric acid, FD&C red #40, glycerin, methylparaben, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
Mfd. for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097
NDC 68258-8000-04
NASAL DECONGESTANT
LIQUID
Pseudoephedrine HCl 30 mg
TEMPORARILY RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES WITHOUT DROWSINESS
•SATISFACTION GUARANTEED•
4 fl oz
(118 mL)
| Class | Version | Type | Effective |
|---|---|---|---|
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-8000-4 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d202-f6ea-e053-dbdaa90aa703 | Rugby ® NASAL DECONGESTANT LIQUID |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-8000-4 | Rugby Nasal DecongestantNasal Decongestant | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-8000 | RUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20111007_8cce0ece-0589-4894-8fd7-bba40eedaa52.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1850-85 | ML - Milliliter | 0536-1850 | 233e0ba0-7061-44a9-abf5-c56adbecab3d | 1 | 2012-07-24 |
| 0536-1850-97 | ML - Milliliter | 0536-1850 | ad2ff551-290e-4f1f-849b-57e8962cf534 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Pseudoephedrine Hydrochloride | ACTIVE INGREDIENT | 6V9V2RYJ8N | 1 | |
| Pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C Red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Raspberry | INACTIVE INGREDIENT | 4N14V5R27W | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68258-8000 | 68258-8000-4 |
| 0536-1850 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Pseudoephedrine Hydrochloride | 6V9V2RYJ8N | ACTIB |
| Sorbitol | 506T60A25R | IACT |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| FD&C Red no. 40 | WZB9127XOA | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Raspberry | 4N14V5R27W | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Benzoate | OJ245FE5EU | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 608 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| Sorbitol | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SWAB / TOPICAL | 0.05 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, COATED / ORAL | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRACARDIAC | 1.05 %w/v | ||
| Sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAMUSCULAR | 864 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7c6d5ac1-5bee-4c72-8240-10a7f2568260 | 8cce0ece-0589-4894-8fd7-bba40eedaa52 | 2011-10-06 | Warnings | 7c6d5ac1-5bee-4c72-8240-10a7f2568260 8cce0ece-0589-4894-8fd7-bba40eedaa52 |
Adverse event summaries are temporarily unavailable. Other product information remains available.